SPL v1
SPL
SPL Set ID 123d1e02-87b8-45d2-90f8-4b83675e526f
Route
ORAL
Published
Effective Date 2021-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.74 g)
Inactive Ingredients
Sorbitol Water Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-02-01

Description

Sodium Monofluorophosphate 0.74%

Purpose

Caries prevention


Medication Information

Purpose

Caries prevention

Description

Sodium Monofluorophosphate 0.74%

Uses

■ Keep your teeth white and strong.

■ Keep your mouth clean.

■ Refresh the inside of the mouth.

■ Prevents tooth decay caused by fluoride and removes bad breath.

■ Increases aesthetic effect.

■ Prevention of plaque deposition, removal of plaque (anti-prag)

Warnings

■ Contains 977ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.

■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

■ Keep out of the reach of children under 6 years of age.

Questions

(+82)1661 - 5981

www.unpacosmetics.com

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient

Sodium Monofluorophosphate 0.74%

Other Information

■ Airtight container, Store in normal temperature (1~30℃)

Inactive Ingredients

Sorbitol, Water, Silica, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Mint Flavor, Carbon, Mentha Piperita (Peppermint) Oil, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract

Keep Out of Reach of Children

■ Keep out of the reach of children under 6 years of age.

Package Label.principal Display Panel


Structured Label Content

Uses

■ Keep your teeth white and strong.

■ Keep your mouth clean.

■ Refresh the inside of the mouth.

■ Prevents tooth decay caused by fluoride and removes bad breath.

■ Increases aesthetic effect.

■ Prevention of plaque deposition, removal of plaque (anti-prag)

Purpose (PURPOSE)

Caries prevention

Warnings (WARNINGS)

■ Contains 977ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.

■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

■ Keep out of the reach of children under 6 years of age.

Questions

(+82)1661 - 5981

www.unpacosmetics.com

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate 0.74%

Other Information

■ Airtight container, Store in normal temperature (1~30℃)

Inactive Ingredients (INACTIVE INGREDIENTS)

Sorbitol, Water, Silica, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Mint Flavor, Carbon, Mentha Piperita (Peppermint) Oil, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

■ Keep out of the reach of children under 6 years of age.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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